BEUDAMED
    FDA Registration Active 🇺🇸 United States

    FENWAL, INC.

    Reg #: 3004548776 · FEI: 3004548776 · Expires 2026
    View on FDA
    Products
    25
    Proprietary Names
    210
    Establishment Types
    2
    Classifications
    25

    Registration Details

    Registration Name
    FENWAL, INC.
    Registration Number
    3004548776
    FEI Number
    3004548776
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    3 CORPORATE DR STE 300
    City
    LAKE ZURICH
    State
    IL
    ZIP
    60047
    Country
    US

    Regulatory Submissions

    510(k) Number
    K200530
    PMA Number
    BP850001

    Owner / Operator

    Firm Name
    Fresenius Kabi AG
    Operator Number
    9027285
    Address
    Else-Kroner-Str. 1
    City
    61352 Bad Homburg
    State
    DE-NOTA
    Postal Code
    NONE
    Country
    DE

    Products

    Device Name Product Code
    Separator, Automated, Blood Cell And Plasma, Therapeutic LKN
    Separator, Automated, Blood Cell, Diagnostic GKT
    Supplies, Blood-Bank KSS
    Container, Empty, For Collection & Processing Of Blood & Blood Components KSR
    Set, Administration, Intravascular FPA
    Pump, Infusion FRN
    Bone Marrow Collection/Transfusion Kit LWE
    Set, Transfer (Blood/Plasma) KSB
    Apparatus, Autotransfusion CAC
    Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use JQC
    Catheter, Irrigation GBX
    System, Processing For Frozen Blood KSW
    Microfilter, Blood Transfusion CAK
    Blood Establishment Computer Software And Accessories MMH
    Set, Blood Transfusion BRZ
    Medical Device Data System OUG
    Device, Heat-Sealing KSD
    Device, Blood Mixing And Blood Weighing KSQ
    Hematocrit, Tube, Rack, Sealer, Holder GHY
    System, Blood Collection, Vacuum-Assisted, Manual KST
    Condenser, Heat And Moisture (Artificial Nose) BYD
    Set, I.V. Fluid Transfer LHI
    Stand, Infusion FOX
    Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use LXG
    Reservoir, Blood, Cardiopulmonary Bypass DTN

    Proprietary Names

    AMICUS Separator System HEMATYPE SEGMENT DEVICE Plasmalink Bottle with Locking Luer Adapter Volumat Line ALYX COMPONENT COLLECTION SYSTEM Adaptive Nomogram Bottle VOLUMAT MC AGILIA VOLUMAT LINES Fenwal Bone Marrow Collection Kit with Accessories BONE MARROW COLLECTION KIT W/ACCESSORIES BONE MARROW COLLECTION KIT WITH ACCESSORIES Bone Marrow Collection Kit and Stand K-Zero Needleless Connector ALYX 2RBC-LR Kit Alyx Component Collection System PLASMA TRANSFER SET Y-Type Connector Set Adaptive Nomogram Transfer Pack Aurora Xi Plasmapheresis System – Software Version 1.3 AMICUS SEPARATOR SYSTEM PLASMACELL-C DISPOSABLE SET AURORA PLASMAPHERESIS SYSTEM CATSmart 60 IN. EXTENSION SET W/ LUER LOCKS 70 IN. EXTENSION GREEN STRIPE TUBING, LL TRIFURCATED EXTENSION, FLL, PINCH CLAMP 288 IN. EXT. SET W/FEMALE/MALE LUER Alyx Cart ALYX COMPONENT COLLECTION SYSTEM (ALYX BY FENWAL) ALYX COMPONENT COLLECTION SYSTEM (ALYX CLASSIC) ALYX COMPONENT COLLECTION SYSTEM, 4R5707 ALYX COMPONENT COLLECTION SYSTEM (ALYX BY FENWAL), 4R5725 Transfer Set AMICUS SEPARATOR, MONONUCLEAR CELL COLLECTION CompoMat G5 Plus and CompoMaster Net G5 Plus Aurora Xi Plasmapheresis System Software Version 2 Glycerolyte 57 Solution SEPACELL PRE-STORAGE LEUKOCYTE REDUCTION SETS FOR RED CELLS ALYX COMPONENT COLLECTION SYSTEM (4R5707, 4R5725) ALYX COMPONENT COLLECTION SYSTEM (6R5725) PLASMALINK POOLING BOTTLE P1R PLASMA TREATMENT SET AS104 AMICUS Apheresis Kit - Double Needle with Inlet Line Sampling Amicus Apheresis Kit - Single Needle AMICUS Apheresis Kit - Double Needle with Platelet Additive Solution Connector AMICUS Apheresis Kit - Single Needle with Platelet Additive Solution Connector Slide Clamp Plasma Extractor DXT Relay CATSmart, Automated Blood Processing Autotransfusion System Y-TYPE BLOOD COMPONENT RECIPIENT SET Blood Component Recipient Set Blood Component Infusion Set CATSmart System ALYX RBC / Plasma Kit Aurora Xi Plasmapheresis System AMICUS EXCHANGE KIT ALYX 2RBC DISPOSABLE SET ALYX Component Collection System ALYX INSTRUMENT DXT RELAY FOR THERAPEUTICS ALYX PLASMA KIT HEAT SEALER CompoSeal Slim DONATION MASTER NT HEMOLIGHT PLUS COMPOGUARD DONATIONMASTER ADVANCE SOFTWARE COMPOGUARD ADVANCE Amicus Apheresis Kit Double Needle Closed Kit Amicus Apheresis Kit Single Needle Functionally Closed Kit Amicus Apheresis Kit Double Needle MNC Kit Amicus Apheresis Kit Double Needle Closed Kit with Platelet Additive Solution (PAS) Connector Amicus Apheresis Kit Single Needle Advanced Kit Platelet Storage Container Amicus Apheresis Kit Double Needle Advanced Kit Amicus Apheresis Kit Single Needle Closed Kit with Platelet Additive Solution (PAS) Connector Amicus Apheresis Kit Double Needle Functionally Closed Kit Amicus Apheresis Kit Single Needle Closed Kit Aurora Plasmapheresis System Aurora Software Version 1.3 Upgrade Kit FRESENIUS KABI DONOR TUBE STRIPPER Adjustable Automatic Donor Scale Support Stand Composeal Universal Composeal Mobilea HemoSeal CompoSeal Mobilea II NPS ACCESS DEVICE MULTI-SAMPLING CONNECTOR LAB EQUIPMENT CompoSampler Aurora Plasmapheresis System Software Version 2.1 ALYX 2RBC LR Kit with Saline Spike Bone Marrow Collection Kit with Flexible Pre-Filter and Inline Filters Bone Marrow Collection Stand COMPODOCK Fenwal Plasmalink Transfer Pack Container with Luer Adapter and No Outlet Ports PLASMACELL Xi Disposable Set COM.TEC CELL SEPARATOR TPE Plasma Exchange Set ALYX 2 RBC-LR Kit AMICUS SEPARATOR, COLLECTION OF THREE PLATELET PRODUCTS PLASTIC STORAGE CONTAINER DXT sanabelle HME-A2 artificial nose for infants; sanabelle HME-A7 artificial nose with valve AMICUS Exchange Kit - Therapeutics Waste Transfer Set Blood Component Filter Set with Vented Spike and Luer Adapter AMICUS APHERESIS KIT-DOUBLE NEEDLE AMICUS APHERESIS KIT-SINGLE NEEDLE AMICUS APHERESIS KIT-DOUBLE NEEDLE W/PAS CONNECTOR AMICUS APHERESIS KIT - SINGLE NEEDLE AMICUS SEPARATOR (4R4580, 4R4580R) AMICUS MNC APHERESIS KIT-DOUBLE NEEDLE AMICUS APHERESIS KIT - DOUBLE NEEDLE W/PAS CONNECTOR AMICUS APHERESIS KIT-SINGLE NEEDLE W/PAS CONNECTOR AMICUS APHERESIS KIT - SINGLE NEEDLE W/PAS CONNECTOR AMICUS MNC APHERESIS KIT - DOUBLE NEEDLE ATY-Y ADAPTER ATO OXYGENATOR LINE ATS SUCTION LINE AUTOPHERESIS-C INSTRUMENT, MODEL A-200 PLASMAPHERESIS INSTRUMENT Plasmacell-C Disposable Set C4L PLATELET SET C4 PLATELET SET Aurora Xi Plasmapheresis System, Software Version 1.2 freeflex+ Transfer Adapter Bone Marrow Collection Kit Bone Marrow Collection Container Amicus Separator System Amicus Apheresis Kit – Functionally Closed Single Needle with PAS Spike and Dual Plasma Containers AMICUS Separator AMICUS Apheresis Kit - Functionally Closed Double Needle with PAS Spike Amicus Apheresis Kit – Functionally Closed Double Needle with PAS Spike and Dual Plasma Containers AMICUS Apheresis Kit - Functionally Closed Single Needle with PAS Spike AMICUS APHERESIS KITS PRODUCT SAMPLE PACK AUTO-C SYSTEM AUTOPHERESIS-C PLASMAPHERESIS SYSTEM AUTOPHERESIS-C SYSTEM EXTENSION 0.2 MICRON FILTER, NEEDLEFREE BLOOD SET 170 MICRON, 2 NEEDLEFREE 6 IN. EXTENSION, 0.2 MICRON AE FILTER BLOOD SET 170 MICRON FILTER NEEDLEFREE 4-WAY HI-FLOW STOPCOCK 40 IN. EXTENSION SET, STOPCOCK 3 IN. EXTEN, 1.2 MICRON AE FILTER BLOOD SET 170 MICRON, PUMP, NEEDLEFREE 3 IN. EXTENSION, 1.2 MICRON AE FILTER EXTENSION, FLL, 0.2 MICRON FILTER MICROBORE EXTENSION, 4-WAY STOPCOCK EXTENSION, 1.2 MICRON FILTER, SLIDE CLMP Y-BLOOD SET 170 MICRONFILTER NEEDLEFREE EXTENSION, 2GANG VALVES, Y-INJ SITE EXTENSION, 3GANG ASV, NEEDLEFREE VALVES EXTENSION, CHECK VALVE, 3GANG VALVES 60 IN. MICROBORE, 0.2 MICRON FILTER LPV KIT, IV POLE 4R4580R - AMICUS SEPARATOR, REFURBISHED 4R4580 - AMICUS SEPARATOR LEUKOCONNECT PRE-STORAGE STERILE CONNECT LEUKOREDUCTION SET W/SEPACELL FILTER FOR RED BLOOD CELLS AMICUS SEPARATOR, RED BLOOD CELL CONCURRENT COLLECTION SEPACELL LEUKOCYTE REDUCTION FILTER FOR RED CELLS SEPACELL R-500II LEUKOCYTE REDUCTION ADMINISTRATION SET FOR RED CELL TRANSFUSION Hand Sealer Hand Sealer Clip COMPOMAT G5 AND COMPOMASTER NET G5 SYSTEM DISPOSABLE APHERESIS KIT Red Blood Cell Freezing Pack Transfer-Pack 20D NON-VENTED, 3 NEEDLEFREE VALVES 20D NON-VENTED, NEEDLEFREE VALVE 20D NON-VENTED, INLINE BCV, NEEDLEFREE 60D VENTED, Y-NEEDLEFREE VALVE 60D VENTED, 2 NEEDLEFREE VALVES 6 IN. EXTENSION SET, NEEDLEFREE VALVE 60 IN. EXTENSION SET W/ NEEDLEFREE VALVE 20D NON-VENTED, BCV, 3 NEEDLEFREE VALVES 60D VENTED, BCV,Y-NEEDLEFREE VALVE EXTENSION SET, 2 -NEEDLEFREE VALVES 60D VENTED, BCV, 2 NEEDLEFREE VALVES 20D NON-VENTED, 2 NEEDLEFREE VALVES EXTENSION T-CONNECTOR, NEEDLEFREE VALVE 20D NON-VENTED, BCV, 2 NEEDLEFREE EXTENSION SET, NEEDLEFREE VALVE 60D VENTED, BCV, 3 NEEDLEFREE VALVES 60D VENTED, 3 NEEDLEFREE VALVES TRIFURCATED EXTENSION, NEEDLEFREE VALVES 4 IN. EXTENSION SET, NEEDLEFREE VALVE BIFURCATED EXTENSION, NEEDLEFREE VALVE AT1 Autotransfusion Set Waste bag 10 L Reinfusion Bag with Y-Adapter ATF 40 Fast Start Kit Reinfusion Bag 1000 mL ATF 120 Fast Start Kit Fresenius CATS Autotransfusion Syst ATR40 FRESENIUS CATS AUT ATR Cap Set ATR120 PSQ PLASMA SEQUESTRATION SET SEPACELL LEUKOCYTE REDUCTION ADMINISTRATION SETS BONE MARROW COLLECTION KIT BONE MARROW COLLECTION STAND Plasmalink Transfer Pack Container – 2000 mL COMPOMASTER NT COMPOMAT G4 AMICUS SEPARATOR

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility